Remimazolam vs Propofol in Laser Burn Cases

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

This randomized, single-blind, crossover study compares remimazolam and propofol for monitored anesthetic care during fractional ablative CO₂ laser therapy for burn scars. The primary aim is to assess incidence of respiratory depression, defined as a need for advanced airway maneuvers (jaw thrust/chin lift, insertion of oral or nasal airway, or bag mask ventilation), and hypopnea (respiratory rate \< 8).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Undergoing both outpatient Session #1 and Session #2 of fractional ablative CO2 laser therapy

Disqualifiers

History of previous fractional ablative laser therapy for burn scar

Procedure expected to last longer than 30 minutes

Allergy such as dextran 40 or contraindication to either of the study drugs

Pregnant and/or breastfeeding

Trial design

Design model

Crossover

Treatments tested in this trial

  • Remimazolam besylate

    Drug

    Remimazolam

  • Propofol

    Drug

    Propofol

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: Remimazolam followed by PropofolActive comparator 2 interventions
Group B: Propofol followed by RemimazolamActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of respiratory depression

The incidence of respiratory depression will include need for advanced airway maneuvers, or hypopnea events. Advanced airway maneuvers during the laser therapy procedure may include jaw thrust, chin lift, insertion of oral or nasal airway, or bag mask ventilation. A hypopnea event is defined as a respiratory rate \<8.

Time frame
up to 24 hours after procedure ends

Secondary outcomes

1

Time from initiation of sedation to peak sedation

Time from initiation of sedation to peak sedation will be measured in minutes and calculated from the start time of induction to peak sedation when patient reaches a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of less than 3. The MOAA/S scale ranges from 0 to 5, with higher scores indicating greater alertness and lower scores indicating deeper sedation: 5: Responds readily to name spoken in a normal tone. 4: Lethargic response to name spoken in a normal tone. 3: Responds only after name is called loudly or repeatedly. 2: Responds only after mild prodding or shaking. 1: Responds only after a painful trapezius squeeze. 0: Does not respond to a painful trapezius squeeze.

Time frame
up to 24 hours after procedure ends
2

Time of cessation of sedation to full recovery

Time of cessation of sedation to full recovery will be evaluated in minutes by marking when the last dose of anesthetic medication is given (cessation of sedation), to when the patient has reached full recovery from anesthesia. Full recovery from anesthesia is defined as when the patient reaches a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≥ 4. The MOAA/S scale ranges from 0 to 5, with higher scores indicating greater alertness and lower scores indicating deeper sedation: 5: Responds readily to name spoken in a normal tone. 4: Lethargic response to name spoken in a normal tone. 3: Responds only after name is called loudly or repeatedly. 2: Responds only after mild prodding or shaking. 1: Responds only after a painful trapezius squeeze. 0: Does not respond to a painful trapezius squeeze.

Time frame
up to 24 hours after procedure ends
3

Cessation of sedation to full recovery

Cessation of sedation to full recovery will also be evaluated as length of PACU stay. This will be measured from the time the patient left the procedure room, to the time they are ready for discharge (marked as procedural care complete).

Time frame
up to 24 hours after the procedure ends
4

Satisfaction with Anesthesia

Satisfaction with Anesthesia will be measured using the Iowa Satisfaction with Anesthesia Scale (ISAS) approximately 15 minutes to two hours after arrival to to the recovery unit. This measures their satisfaction with Monitored Anesthesia Care (MAC). ISAS is an 11-item questionnaire designed to measure the satisfaction with monitored anesthesia care. The ISAS score is the mean of responses to all 11 questions. The score ranges from a minimum of -3 to a maximum of +3 when averaged together. The responses are: -3 = disagree very much, -2 = disagree moderately, -1 = disagree slightly, 1 = agree slightly, 2 = agree moderately, and 3 = agree very much. A score of +3 would imply a completely satisfied patient.

Time frame
up to 24 hours after the procedure ends

Other outcomes

1

Incidence of hypotension

Incidence of hypotension during the procedure will measured by the use of vasopressors such as Norepinephrine or equivalent, as well as the lowest blood pressure reading during the procedure.

Time frame
up to 24 hours after the procedure ends
2

Incidence of low EtCO2

Incidence of low EtCO2 will be measured by recording the lowest intraoperative EtCO2 reading during the procedure.

Time frame
up to 24 hours after the procedure ends
3

Incidence of hypoxemia

Baseline SpO2 and lowest SpO2 will be recorded to evaluate incidence of hypoxemia during the procedure.

Time frame
up to 24 hours after the procedure ends

Sponsors and contacts

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